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Abstract:

A venous access port assembly having a housing base, a flange, and a
septum. The housing base defines an interior reservoir. The flange
includes integrally molded X-ray discernable indicia identifying that the
assembly is rated for power injection. The X-ray discernable indicia may
extend through a height of the flange from a top surface to a bottom
surface of the flange. According to one aspect, the flange may be formed
from X-ray discernable material, and the X-ray discernable indicia may be
formed from the X-ray discernable material of the flange, or they may be
formed by voids in the X-ray discernable material. According to another
aspect, the flange may be formed from a radiotransparent or radiolucent
material and applied with a radiopaque agent, and the X-ray discernable
indicia may be one or more voids in the radiopaque agent or may be
portions of the flange applied with the radiopaque agent.

Claims:

1. A venous access port assembly for implantation into a patient,
comprising: a housing comprising: a base defining at least one reservoir;
and a flange adjacent to the at least one reservoir, the flange
comprising X-ray discernable indicia configured to indicate, under X-ray
examination, that the assembly is rated for power injection; and a
needle-penetrable septum communicating with the housing.

2. The assembly of claim 1, wherein the flange further comprises an X-ray
discernable material, and the X-ray discernable indicia are formed of the
X-ray discernable material.

3. The assembly of claim 2, wherein the flange further comprises one or
more voids in the X-ray discernable material, and one or more of the
X-ray discernable indicia are disposed within respective ones of the one
or more voids.

4. The assembly of claim 1, wherein the flange comprises an X-ray
discernable material and one or more voids in the X-ray discernable
material, and wherein the one or more voids in the X-ray discernable
material are the X-ray discernable indicia.

5. The assembly of claim 1, wherein the flange extends outwardly from the
at least one reservoir.

6. The assembly of claim 1, wherein the flange extends outwardly from the
base about a perimeter of the at least one reservoir.

7. The assembly of claim 1, wherein the housing further comprises a skirt
overmolded about at least a portion of the base.

8. The assembly of claim 7, wherein the skirt is further overmolded about
the flange.

9. The assembly of claim 7, wherein the skirt comprises a
radiotransparent or radiolucent material.

10. The assembly of claim 1, wherein the X-ray discernable indicia
further indicate, under X-ray examination, that the assembly is adapted
to withstand high pressures used for injection of contrast fluid.

11. The assembly of claim 1, wherein the X-ray discernable indicia extend
through a height of the flange from a top surface of the flange to a
bottom surface of the flange.

12. A venous access port assembly for implantation into a patient,
comprising: a housing comprising: a housing base defining at least one
reservoir; and a flange adjacent to the at least one reservoir, the
flange comprising X-ray discernable indicia configured to indicate, under
X-ray examination, that the assembly is rated for power injection; and a
needle-penetrable septum secured to the housing.

13. The venous access port assembly of claim 12, wherein the flange is
comprised of X-ray discernable material, and wherein the flange further
comprises a top surface, a bottom surface, and one or more voids
extending through a height of the flange from the top surface of the
flange to the bottom surface of the flange.

14. The venous access port assembly of claim 13, wherein the X-ray
discernable indicia are the one or more voids in the flange.

15. The venous access port assembly of claim 13, wherein X-ray
discernable indicia are disposed within the one or more voids in the
flange and are comprised of the X-ray discernable material.

16. The venous access port assembly of claim 12, wherein the flange
extends outwardly from the at least one reservoir.

17. The venous access port assembly of claim 12, wherein the flange
extends outwardly from the housing base about a perimeter of the at least
one reservoir.

18. The venous access port assembly of claim 12, wherein the housing
further comprises a radiotransparent or radiolucent skirt overmolded
about at least a portion of the housing base.

19. The venous access port assembly of claim 18, wherein the
radiotransparent or radiolucent skirt is further overmolded about the
flange.

20. The venous access port assembly of claim 12, wherein the X-ray
discernable indicia further indicate, under X-ray examination, that the
assembly is adapted to withstand high pressures used for injection of
contrast fluid.

21. A venous access port assembly for implantation into a patient,
comprising: a housing comprising: a housing base comprising a well
comprising a bottom floor and side walls, the bottom floor and side walls
defining at least one reservoir; and a flange adjacent to the at least
one reservoir, the flange comprising X-ray discernable indicia configured
to indicate, under X-ray examination, that the assembly is rated for
power injection; a needle-penetrable septum; and a cap securing the
needle-penetrable septum to the housing.

22. The venous access port assembly of claim 21, wherein the flange is
comprised of X-ray discernable material, and wherein the flange further
comprises a top surface, a bottom surface, and one or more voids
extending through a height of the flange from the top surface of the
flange to the bottom surface of a flange.

23. The venous access port assembly of claim 22, wherein the X-ray
discernable indicia are the one or more voids in the flange.

24. The venous access port assembly of claim 22, wherein X-ray
discernable indicia are disposed within the one or more voids in the
flange and are comprised of the X-ray discernable material.

26. The venous access port assembly of claim 21, wherein the flange
extends outwardly from the housing base about a perimeter of the at least
one reservoir.

27. The venous access port assembly of claim 21, wherein the housing
further comprises a radiotransparent or radiolucent skirt overmolded
about at least a portion of the housing base.

28. The venous access port assembly of claim 27, wherein the
radiotransparent or radiolucent skirt is further overmolded about the
flange.

29. The venous access port assembly of claim 21, wherein the X-ray
discernable indicia further indicate, under X-ray examination, that the
assembly is adapted to withstand high pressures used for injection of
contrast fluid.

[0003] Venous access ports for the infusion and/or withdrawal of fluids
from a patient are well-known, secured to the proximal end of an
implanted catheter. These ports are typically used for drug infusion or
for withdrawal of small amounts of blood, where large flows of fluid are
not required. The ports are assemblies of a needle-impenetrable housing
with a discharge port in fluid communication with a catheter and a
reservoir within the port housing, and provide a subcutaneous
self-sealing septum that defines an access site for multiple needle
sticks through the covering skin tissue of the patient, through the
septum, and into the reservoir, without the need to continuously search
for new access sites. Examples of such ports are disclosed, for example,
in U.S. Pat. Nos. 4,704,103; 4,762,517; 4,778,452; 5,185,003; 5,213,574;
and 5,637,102.

[0004] It is desired to provide a venous access port assembly that
provides a medical practitioner with the capability to discern an
important property of the port assembly after the port assembly has been
implanted into a patient.

BRIEF SUMMARY OF THE INVENTION

[0005] The present invention is directed to an implantable venous access
port having a marking visible by X-ray examination, providing
identification on the X-ray of characteristics of the implanted access
port. These characteristics might otherwise be unknown once the port is
implanted under the skin of the patient. Considering that X-ray
examination is normal practice prior to medical access of the port, an
X-ray examination that also identifies important characteristics of an
implanted port is beneficial to the practitioner.

[0006] Accordingly, one aspect of the present invention is the
incorporation of a molded marking into or onto the venous access port, or
the addition of radiopaque indicia onto the access port, and/or the
addition of radiopaque indicia onto a molded marking integrated into the
access port, all of which would be discernable under X-ray examination to
provide information concerning a characteristic or attribute of the
venous access port, so that a practitioner, subsequent to implantation of
the access port under the skin of a patient, can determine that
characteristic or attribute of the port by X-ray examination.

[0007] One such characteristic could be power injectable capability; that
is, an indication that the venous access port is rated for the power
injection of contrast fluid. Power injection capability can be indicated
with the letters "CT," for "computed tomography," or "contrast enhanced
computed tomography." "CT" would indicate the access port's capability to
withstand high pressures used during injection of contrast fluid into a
patient, and the letters "CT" would be understood in medical practice to
indicate that the port is suitable for the high pressure injection of
contrast fluid. Naturally, any characteristic or attribute of the venous
access port could be indicated, and any choice of letters or symbols
could be employed.

[0008] In one embodiment, an access port of the present invention includes
a housing and a septum, providing an interior reservoir and a passageway
extending from the reservoir through a stem of a discharge port to
establish fluid communication with a proximal end of a catheter lumen to
which the port assembly is secured prior to placement of the assembly
into a patient. The port may optionally have more than one reservoir and
associated septum. The housing could include molded therein the letters
"CT." If the housing is made of a plastic material, such as a silicone
elastomer, the letters "CT" (or the entire housing) could be loaded with
a radiopaque agent, allowing the letters "CT" (or the entire housing) to
be seen by X-ray examination. If the housing comprises a metal material,
or if the portion of the housing including the letters "CT" is made of a
metal material, the letters would naturally be visible by X-ray
examination.

BRIEF DESCRIPTION OF THE DRAWINGS

[0009] The accompanying drawings, which are incorporated herein and
constitute part of this specification, illustrate the presently preferred
embodiments of the invention, and, together with the general description
given above and the detailed description given below, serve to explain
the features of the invention. In the drawings:

[0010] FIG. 1 is an isometric view of one embodiment of a venous access
port of the present invention;

[0012] FIGS. 3 and 4 are cross-sectional views of the port of FIGS. 1 and
2 taken along lines 3-3 and lines 4-4 of FIG. 2, respectively;

[0013]FIG. 5 is an isometric view of a needle-impenetrable housing base
of the venous access port of FIG. 1;

[0014] FIGS. 6 and 7 are transverse cross-sectional and longitudinal
cross-sectional views of the housing base of FIG. 5;

[0015]FIG. 8 is an isometric view from below of one embodiment of the
housing base of FIG. 5, showing radiopaque indicia applied on the housing
base bottom surface;

[0016] FIGS. 9 and 10 are bottom and top views of the housing base of FIG.
8 having radiopaque indicia thereon, with the top view (FIG. 10) being
analogous to a X-ray view of the venous access port seen by a
radiologist, with indicia visible by X-ray shown by dashed lines in FIG.
10;

[0018]FIG. 12 illustrates an isometric view of one of the FIG. 11
embodiments of the needle-impenetrable housing base of the venous access
port of FIG. 1, featuring an integrally molded "CT" marking where the
letters "CT" are formed of housing material; and

[0019]FIG. 13 illustrates an isometric view of the other of the FIG. 11
embodiments of the needle-impenetrable housing base of the venous access
port of FIG. 1, featuring an integrally molded "CT" marking where the
letters "CT" comprise voids in the housing material, as if cut or punched
out of the housing material.

DETAILED DESCRIPTION OF THE INVENTION

[0020] Certain terminology is used herein for convenience only and is not
to be taken as a limitation on the present invention. The terms "distal"
and "proximal" refer, respectively, to directions closer to and away from
the insertion tip of a catheter in an implantable catheter assembly. The
terminology includes the words specifically mentioned, derivatives
thereof, and words of similar import. The embodiments illustrated below
are not intended to be exhaustive or to limit the invention to the
precise form disclosed. These embodiments are chosen and described to
best explain the principle of the invention and its application and
practical use and to enable others skilled in the art to best utilize the
invention.

[0021] Venous access port assembly 10 of FIGS. 1 to 4 includes a housing
12 and a septum 14, with a discharge port 16 extending from a distal end
18 of the port assembly 10 to be attached securely and sealingly to the
proximal end of a catheter (not shown). A passageway 20 extends from the
interior reservoir 22 to the distal tip opening 24 of discharge port 16.
A recess 26 is seen to be provided along both sides of discharge port 16,
facilitating insertion of the discharge port 16 into the catheter lumen
and providing a clearance for a locking sleeve or clamp (not shown)
utilized to compress the catheter lumen wall against the exterior surface
of the discharge port 16 for assured sealed connection of the catheter
with the port assembly 10.

[0022] With reference now to FIGS. 3 to 7, the interior of the port
assembly 10 is shown to provide an interior reservoir 22. Housing 12 is
shown to include a housing base 28 of needle-impenetrable material that
includes a well 30 having a bottom floor 32 and side walls 34 that define
the interior reservoir 22 beneath septum 14. Bottom floor 32 may be
convex or elevated (not shown) toward the center of the reservoir, if
desired. Housing base 28 includes a base flange 36 extending radially
outwardly from the bottom of well 30, and base flange 36 includes
openings 38, 40 that serve to enable suturing to the patient upon
placement of the venous access port and the attached catheter into the
patient.

[0023] As shown in FIGS. 3 and 4, a skirt 42 is overmolded about housing
base 28 and may be of silicone elastomer. It is seen that skirt 42
encapsulates the outer surfaces of the bottom wall 44 and the bottom
portion of the side walls 46 of housing base 28, and is shown to fill in
the suture holes 38, 40; but since the material is silicone elastomer,
suturing is possible since the suturing needle can easily be inserted
through the material of skirt 42 and through the suture holes, and
thereafter the filled openings provide minimal opportunity for ingrowth
of patient tissue into the openings.

[0024] Also seen in FIGS. 1 to 4 is cap 48, which secures to housing base
28 to in turn secure septum 14 in position in the port assembly 10.
Preferably, skirt 42 is insert molded onto base flange 36 of housing base
28 after cap 48 is secured to the upper portion of housing base 28 to
secure the septum in position. It is seen in FIGS. 4 and 7 that discharge
port 16 is integral with housing base 28 as is preferable. Discharge port
16 is shown to have a pair of annular ridges 50 that facilitate with the
mechanical connection of the catheter proximal end with the port assembly
10. Housing base 28 includes a septum seat 52 extending into the top of
well 30, into which a flange of the septum will be seated, preferably
under radially inward compression. Housing base 28 has a bottom outer
surface 54.

[0025] Radiopaque markings 60 of the present invention are shown in FIGS.
8 to 10. A larger outer circle 62 is seen provided on the outermost
periphery of bottom base surface 54, and a smaller inner circle 64 is
seen provided within the area circumscribed by the suture openings 38 and
holes 40 through base flange 36. Adjacent to discharge port 16, a recess
56 is provided in the skirt of the housing base to provide a clearance
for use of a connection sleeve that will be used to secure the catheter
(not shown), and outer circle 62 is shown to have a gap 66 at the recess.
Outer and inner circles or rings 62, 64 circumscribe radiopaque indicia
70.

[0026] Radiopaque indicia 70 are provided on bottom outer surface 54
within the region directly beneath the reservoir and septum. In the
example shown, indicia 70 comprise the letters "CT" (FIG. 10)
representing the term "computed tomography." The meaning of this
particular example of indicia is that the venous access port assembly 10
is rated for high pressure injection such as is necessary for infusion
into the patient of contrast medium that is used in computed tomography.
Other indicia may of course be used that indicate some other attribute or
characteristic of the venous access port assembly. The radiopaque
markings and indicia would appear on an X-ray of the patient, and the
indicia are provided in a mirror-image orientation on the bottom outer
surface of the housing base (FIGS. 7 and 8) so that the indicia would
appear as "CT" when the X-ray is viewed (FIG. 9), easily discerned by the
radiologist or technologist.

[0027] Centering of the indicia within the region (identified as "30, 22"
in FIG. 10) directly beneath the reservoir and septum minimizes any
obscuring by the structure of the venous access port assembly, and the
indicia may also be easily discernable should the port assembly be at an
angle from the horizontal plane of the X-ray; the outer and inner circles
62, 64 would appear oval or elliptical should the port assembly be at
such an angle. Gap 66 in outer circle 62 would also appear and would
indicate the location of the discharge port stem 16.

[0028] The radiopaque markings may constitute marking fluid that is
embossed or imprinted or otherwise applied onto the surface of the
housing base 28, such as black radiopaque ink Part No. C11002 Rev A
formulated by Creative Imprinting of Erie, Pa., from Marabu Tampapur TPU
910 clear with tungsten added, available from Marabuwerke GmbH & Co. KG
of Stuttgart, Germany, and may be applied on plasma-treated surfaces. At
least the housing base 28, the septum 14 and the skirt 42 are of
radiotransparent or radiolucent material as is well known in implanted
medical devices, and the housing base may be molded of polysulfone resin.

[0029] The radiopaque markings may alternatively applied to the inwardly
facing surface of the bottom wall of the housing base, or may constitute
foil or film (such as a decal) of radiopaque material embedded within the
housing base, these alternatives not being shown in the drawings.

[0030]FIG. 11 illustrates top views of two alternative embodiments 72, 74
of the needle-impenetrable housing base 28 of the venous access port 10
of the present invention. Each of the alternative embodiments 72, 74
shows "CT" markings integrally formed in the base flange 36 of the
housing base 28. The first alternative embodiment 72, an isometric view
of which is illustrated in FIG. 12, features integrally molded "CT"
markings within the suture openings 38, where the letters "CT" are formed
of the base flange 36 material. The second alternative embodiment 74, an
isometric view of which is illustrated in FIG. 13, features integrally
molded "CT" markings alongside the suture openings 38, 40, where the
markings are voids in the base flange 36 material, as if cut or punched
out of the base flange 36 material. Naturally, the markings could be
configured elsewhere within or about the housing base 28, or within a
peripheral portion of another component of the venous access port 10.

[0031] If the housing base 28 is made of a plastic material, such as a
silicone elastomer or polysulfone resin, the letters "CT," or the base
flange 36, or the entire housing base 28, could be applied with a
radiopaque agent or fluid, allowing the applied area to be visible by
X-ray examination. If the housing base 28 is comprised of a metal
material, or if the base flange 36, or a portion thereof, is comprised of
metal (particularly the letters "CT"), those portions would naturally be
visible by X-ray examination without application of the radiopaque agent.

[0032] It will be appreciated by those skilled in the art that changes
could be made to the embodiments described above without departing from
the broad inventive concept thereof. It is understood, therefore, that
this invention is not limited to the particular embodiments disclosed,
but it is intended to cover modifications within the spirit and scope of
the present invention as defined by the appended claims.

Patent applications by Kenneth M. Zinn, Westport, CT US

Patent applications by Kevin E. Sanford, Chalfont, PA US

Patent applications by Raymond R. Bizup, Feasterville, PA US

Patent applications by Timothy M. Schweikert, Levittown, PA US

Patent applications by Innovative Medical Devices, LLC

Patent applications by Medical Components, Inc.

Patent applications in class Detectable material placed in body

Patent applications in all subclasses Detectable material placed in body